Why does the FDA hide information about its advisory committee members?

Thank you,  Public Citizen, for suing the FDA to require it to disclose the full curriculum vitae (CVs) of the members of its advisory committees. And thank you, Common Dreams, for reporting on it.

Let me elaborate. The FDA uses advisory committees to get a variety of independent scientific opinion on matters that come before it, such as: (1) whether to approve an application for a new drug; or (2) what conditions should be imposed on the labeling or sale of drugs or medical devices. (You may recall that the FDA’s action on the Plan B contraceptive became controversial after the FDA disregarded the recommendation of the committee for what appeared to be political reasons.)

As the FDA explains here, individuals who wish to be considered for membership on an  FDA Advisory Committee must submit a detailed CV and information about their employment, grants received, and financial holdings so that the FDA can determine whether there is a potential conflict of interest,  Note that a CV would not include financial holdings, nor would it contain details of grants received.

The basis for the Public Citizen lawsuit is that the FDA redacts information from the CVs of members of its advisory committees. According to Public Citizen, when it requested CVs of members of advisory committees under the Freedom of Information Act (FOIA) (5 U.S.C. §552), the FDA redacted information, sometimes without any explanation under the FOIA, and sometimes stating that disclosure would constitute a clearly unwarranted invasion of privacy.

For example, Dr. Michael A. Carome, a director of Public Citizen, serves on the FDA Advisory Committee on Pharmacy Compounding. His CV is available here on the FDA web site. Dr. Carome gave his permission for the entire CV to be disclosed to the public when he submitted it. Yet, Dr. Carome told Public Citizen that the FDA redacted information about a research grant he received in 1996 and 1997 and medals he earned in the military.

The names of academic mentors are commonly removed. Redactions to other CVs on the agency web site deleted the nature and subject of grants, patents and cooperative agreements, “research interests,” or specific papers or presentations. According to Public Citizen, the FDA routinely redacts the dates that academic degrees were awarded.

 

 

 

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